In the U.S.—

• Smoking cessation adjunct

Nicotine ( NIK-oh-teen) in a nasal spray is used to help you stop smoking. It is used for up to 3 months as part of a stop-smoking program. This program may include counseling, education, or psychological support.

With the nasal spray, nicotine is inhaled through your nose and passes into your blood stream. This nicotine takes the place of the nicotine you would otherwise get from smoking. In this way, the withdrawal effects of not smoking are less severe. Then, as your body adjusts to not smoking, the use of nicotine nasal spray is decreased gradually over several weeks. Finally, use is stopped altogether.

This medicine is available only with your doctor's prescription, in the following dosage form:

Nasal
• Nasal spray (U.S.)

In deciding to use a medicine, the risks of using the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For nicotine, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to nicotine. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Nicotine, whether from smoking or from the nasal spray, is not recommended during pregnancy. Studies in animals have shown that nicotine can cause harmful effects in the fetus.

Breast-feeding—Nicotine passes into breast milk and may cause unwanted effects in the baby. It may be necessary for you to stop breast-feeding during treatment.

Children—Small amounts of nicotine can cause poisoning in children.

Older adults—This medicine has been tested in a limited number of patients 60 years of age or older and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are using nicotine nasal spray, it is especially important that your health care professional know if you are taking any of the following medicines:

• Beta-adrenergic blocking agents (acebutolol [e.g., Sectral], atenolol [e.g., Tenormin], betaxolol [e.g., Kerlone], bisoprolol [e.g., Zebeta], carteolol [e.g., Cartrol], labetalol [e.g., Trandate], metoprolol [e.g., Lopressor], nadolol [e.g., Corgard], oxprenolol [e.g., Trasicor], penbutolol [e.g., Levatol], pindolol [e.g., Visken], propranolol [e.g., Inderal], sotalol [e.g., Betapace], timolol [e.g., Blocadren]) or
• Insulin or
• Theophylline (e.g., Theo-Dur)—Stopping smoking may increase the effects of these medicines; the amount of medicine you need may change

• Allergies or
• Heart or blood vessel disease or
• High blood pressure or
• Liver disease or
• Nose polyps or
• Overactive thyroid or
• Pheochromocytoma or
• Sinus problems or
• Stomach ulcer or
• Type 1 diabetes (sugar diabetes)—Nicotine may make the condition worse

• Common cold or
• Stuffy nose—Nicotine nasal spray may not work properly

Nicotine nasal spray usually comes with patient directions. Read the directions carefully before using this medicine.

It is important to participate in a stop-smoking program during treatment. To do so may make it easier for you to stop smoking.

Use of nicotine nasal spray may be gradually reduced by using only one half of a dose at a time or skipping doses by not using the spray every hour. You may also keep track of the number of doses and use fewer each day, or set a date to stop using nicotine nasal spray.

Dosing—

The dose of nicotine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of nicotine. If your dose is different, do not change it unless your doctor tells you to do so.

• For the nasal spray dosage form:
  • To help you stop smoking:
    • Adults—At first, the dose is 1 or 2 sprays into each nostril every hour. The dose should then be adjusted based on the number of cigarettes you smoked each day before beginning treatment with the nasal spray and the side effects the nasal spray causes.
    • Children—Use and dose must be determined by your doctor.

Storage—

To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Keep the medicine from freezing. Do not refrigerate.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Nicotine nasal spray should not be used by people who do not smoke because they can become addicted to nicotine.

During the first week of use, you may have a hot, peppery feeling in the back of your throat or nose; coughing; runny nose; sneezing; or watery eyes. Do not stop using this medicine. If you continue to use nicotine nasal spray regularly, you should adjust to these effects. If these effects do not lessen after 1 week, check with your doctor.

Avoid contact with the skin, mouth, eyes, and ears . If even a small amount of nicotine nasal spray comes into contact with the skin, mouth, eyes, or ears, the affected area should be immediately rinsed with water only.

Do not use nicotine nasal spray for longer than 3 months . To do so may result in physical dependence on the nicotine.

Nicotine should not be used in pregnancy. If there is a possibility you might become pregnant, you may want to use some type of birth control. If you think you may have become pregnant, stop using this medicine immediately and check with your doctor.

Nicotine products must be kept out of the reach of children and pets. Even very small amounts of nicotine may cause poisoning in children. If a child uses nicotine nasal spray, contact your doctor or poison control center at once.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• More common
  • Feelings of dependence;  joint pain;  shortness of breath;  swelling of gums, mouth, or tongue;  tightness in chest;  tingling in arms, legs, hands, or feet 
  
  

• Less common
  • Burning, tingling, or prickly sensations in nose, mouth, or head ;  confusion;  difficulty in swallowing;  dryness or pain in throat;  fast or irregular heartbeat;  muscle pain;  nasal blister or sore;  numbness of nose or mouth 
  
  

• Rare
  • Blood-containing blisters on skin;  difficulty in speaking;  loss of memory;  migraine headache;  skin rash;  swelling of feet or lower legs;  wheezing  
  
  

• Symptoms of overdose
  • Cold sweat;  convulsions (seizures);  disturbed hearing and vision;  dizziness ;  drooling;  pale skin;  slow heartbeat;  tremors;  vomiting;  unusual tiredness or weakness  
  
  

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

• More common
  • Back pain;  constipation;  cough;  headache;  hot, peppery feeling in the back of the throat or nose;  indigestion;  nausea;  runny nose;  sneezing;  watery eyes  
  
  

• Less common
  • Abdominal or stomach pain;  acne;  change in sense of smell or taste;  dryness, burning, itching, or irritation of the eyes;  earache;  flushing of face;  passing of gas;  hoarseness;  itching;  menstrual problems;  nosebleed;  sinus problems;  soreness of teeth and gums;  stuffy nose 
  
  

• Rare
  • Changes in vision;  diarrhea;  dryness of mouth;  hiccups;  increased amount of sputum 
  
  

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.